JP2012508616A - Access device - Google Patents

Abstract

  The access device places the medical article inside the patient's body space. The device includes a needle that includes an elongated body and a needle hub. The medical article can be placed over the needle and slide over the needle. A torsion space is provided at an arbitrary position between the needle and the outer surface of the medical article. This torrent space communicates with the needle hole and the variable volume chamber. Thus, the variable volume chamber can draw fluid from the torrent space into the chamber.

Description

<Cross-reference to related applications>
This application relates to US Provisional Patent Application Nos. 61 / 113,989 (filed on Nov. 12, 2008) and 61 / 114,404 (filed on Nov. 13, 2008). And claims their benefit under 35 USC 119 (e), each of which is expressly incorporated herein by reference in its entirety. Be incorporated.

<Field of Invention>
The invention generally introduces a medical article (such as a catheter, cannula, sheath, etc.) into a body space, such as an artery, vein, blood vessel, body cavity, or drainage site, and / or , Directed to an access device for delivery.

<Description of related technologies>
Preferred non-surgical methods for inserting a catheter or vascular sheath into a blood vessel include the use of a Seldinger technique or modified Seldinger method involving an access needle inserted into a patient's blood vessel. It is. A guide wire is inserted through the needle and into the blood vessel. The needle is removed and the dilator and sheath are inserted over the guidewire, either in combination or separately. The dilator and the sheath are then inserted together or separately through the tissue and into the blood vessel for a short distance, after which the dilator and the guidewire are removed and discarded. A catheter or other medical article can then be inserted into the blood vessel through the sheath to the desired location, or the sheath can remain in the blood vessel.

  Many vascular access devices are known. U.S. Pat.Nos. 4,241,019, 4,289,450, 4,756,230, 4,978,334, 5,124,544, 5,424,410, 5,312,355 No. 5,212,052, 5,558,132, 5,885,217, 6,120,460, 6,179,823, 6,210,332, 6,726,659 And US Pat. Nos. 7,025,746 disclose examples of such devices.

  However, none of these devices provide the ease of use and safety that would be preferable to a physician or medical service provider. For this reason, a vascular access device that is easier to use and safer, in particular the device that will clearly and quickly indicate when a blood vessel has been punctured, and an overwire vascular access device There is a need for such devices that will reduce inadvertent needlestick injuries and other attendant risks.

  Embodiments of the present invention include several features of an access device that is useful for delivering a catheter or sheath into a space within a patient's body, such as a blood vessel or drainage site. A typical structure is included. Without departing from the scope of the invention, its more prominent features will be briefly discussed. Several have given these advantages over conventional access devices after considering this discussion and, inter alia, after reading the detailed description section of the preferred embodiment below in combination with the description of this section. It will be understood how this is brought about by the characteristic configurations and aspects of the embodiments.

  In one embodiment, an access device can be provided for placing the medical article within the body space. The access device may include a needle and a medical article disposed over at least a portion of the needle. The needle may include a hole, and the hole may communicate with a torsional space created anywhere between the needle and the outer surface of the medical article. Moreover, this torsion space may be connected to the variable volume chamber. As a result, the variable volume chamber can draw fluid from the perturbation space into the chamber.

  In another embodiment, another access device may be provided for placing the medical article inside the body space. As in the previous embodiment, a needle, a medical article, and a torsion space can be provided. Furthermore, the extended passage can be communicated to the torsion space at the first end and to the negative pressure element at the second end. A filtration element may be placed in any of the negative pressure element, tube, or perfusion chamber. As a result, this filtering element can prevent the outflow of bodily fluid entering the perfusion chamber, but allows the outflow of air to the negative pressure element.

  These and other characteristic features, aspects and advantages of the access device disclosed in this specification are intended to illustrate the invention and are not intended to be limiting The following description is made with reference to the drawings of the embodiments. In addition, throughout these figures, the same reference numerals are used to denote the same components of the illustrated embodiment. Similar components in the illustrated embodiments are similarly represented as identical reference numerals with subscripts to indicate another embodiment. The following is a brief description of each of these drawings.

1 is a perspective view of a preferred embodiment of an access device constructed in accordance with the present invention, and also shows a pre-mounted guidewire portion that is coaxially aligned with a needle, dilator, and medical article. FIG.

1B is a plan view of the embodiment depicted in FIG. 1A. FIG.

1B is a plan view of the needle in FIG. 1A and also shows a window hole near the distal end.

1B is a side view of the needle in FIG. 1A and also shows a fin near the proximal end.

It is sectional drawing which followed the 2C-2C line | wire in FIG. 2A.

FIG. 2B is an enlarged plan view of a part of the needle in FIG. 2A and also shows the window hole.

2B is an enlarged plan view of the needle hub of the needle in FIG. 2A. FIG.

2B is an enlarged side view of the needle hub of the needle in FIG. 2A. FIG.

2B is an enlarged proximal end view of the needle hub of the needle in FIG. 2A. FIG.

1B is a plan view of the dilator in FIG. 1A and also shows a window hole near the distal end. FIG. 3A also shows a longitudinal groove in the luer surface for venting air between the dilator and the sheath.

FIG. 3B is a cross-sectional view taken along line 3B-3B in FIG. 3A.

3B is an enlarged plan view of a portion of the dilator in FIG. 3A and also shows the window holes and longitudinal grooves.

3B is an enlarged end view of the dilator hub in FIG. 3A. FIG.

FIG. 10 is a perspective view of another embodiment of a dilator hub that includes a locking spin nut configured to be secured to a sheath with corresponding threads.

It is sectional drawing along the 3F-3F line | wire in FIG. 3A, and the groove | channel arrange | positioned at equal intervals around the periphery in the lure surface is also shown.

FIG. 1B is a plan view of the sheath in FIG. 1A and also shows a sheath hub connected to the proximal end of the sheath.

FIG. 4B is a cross-sectional view taken along line 4B-4B in FIG. 4A.

FIG. 4B is an enlarged end view of the sheath in FIG. 4A.

FIG. 4B is an enlarged perspective view of the proximal portion of the sheath in FIG. 4A.

1B is a perspective view of the guidewire portion in FIG. 1A and also shows a guidewire hub connected to the proximal end of the guidewire. FIG.

FIG. 5B is a plan view of the guidewire portion of the embodiment depicted in FIG. 5A.

It is a perspective view of the sending body in Drawing 1A.

FIG. 6B is a plan view of the path body in FIG. 6A and also shows a fixing mechanism for fixing the needle to the dilator.

It is a side view of the sending body in Drawing 6B.

It is an enlarged view of the fixing mechanism in FIG. 6B.

It is an enlarged view of another fixing mechanism which fixes a guide wire part to a pre-loading state.

FIG. 6 is a plan view of the approaching device in FIG. 1A, and the fixing mechanism in FIG.

FIG. 7B is a side view of the access device and the fixing mechanism in FIG. 7A.

FIG. 7B is a cross-sectional view of the access device in FIG. 7A and also shows a guide wire hub disposed between an element in the path body and a stop.

FIG. 7B is an enlarged end view of the access device in FIG. 7B and also shows two arms extending from the path body and extending around at least a portion of the guidewire hub.

FIG. 1B is a plan view of the embodiment depicted in FIG. 1A illustrating the insertion of an access device into a patient's body.

FIG. 8B is an enlarged view of the embodiment depicted in FIG. 8A focusing on the area of the access device adjacent to the patient.

FIG. 8B is an enlarged view of a portion of the embodiment depicted in FIG. 8B, and also shows the needle opening or window hole aligned with the dilator opening or window hole in hidden lines.

FIG. 8C is an enlarged cross-sectional view of a portion of the embodiment depicted in FIG. 8C and also allows the fluid to flow from the inside of the needle to the flow path formed between the sheath and the dilator. Also shown is the needle opening or window hole aligned with the opening or window hole.

It is a graph which shows the speed | rate which the fluid is pulled up to a flow path with a gap height width of 0.002 inches.

It is a graph which shows the speed | rate which the fluid is pulled up to a flow path with a gap height width of 0.001 inches.

It is a graph which shows the speed | rate which the fluid is pulled up to the flow path with the gap height width of 0.0005 inches.

FIG. 9 is an enlarged cross-sectional view of the portion of the embodiment depicted in FIG. 8C along a region distal to the flow path in the dilator.

FIG. 8B is an enlarged view of the embodiment depicted in FIG. 8A, focusing on the area where the needle hub is secured to the dilator hub when the needle hub is in the first position.

FIG. 8I is a cross-sectional view of the embodiment depicted in FIG. 8I.

1B is a side view of the embodiment depicted in FIG. 1A illustrating a guidewire advanced distally from the tip of a needle. FIG.

FIG. 9B is an enlarged view of the embodiment depicted in FIG. 9A, focusing on the area where the guidewire hub is secured to the needle hub when the needle hub is in the first position.

FIG. 9B is a cross-sectional view of the embodiment depicted in FIG. 9B.

FIG. 9B is a side view of the embodiment depicted in FIG. 1A, illustrating the dilator and sheath being advanced distally relative to the needle body from the position illustrated in FIG. 9A.

FIG. 10B is an enlarged rear view of the embodiment depicted in FIG. 10A, focusing on the area where the needle hub is secured to the channel when the needle hub is in the second position.

FIG. 1B is a side view of the embodiment depicted in FIG. 1A illustrating the removal of a guidewire, needle body, and dilator from the sheath.

FIG. 11B is an enlarged view of a portion of the embodiment illustrated in FIG. 11A, showing the guidewire, needle body, and needle tip covered by the dilator during removal of the dilator.

FIG. 6 is an enlarged plan view illustrating another embodiment of an aligned opening or window hole in the needle and dilator.

FIG. 13B is an enlarged cross-sectional view taken along line 13B-13B in FIG. 12A and allows the dilator to open or to allow fluid to flow from the inside of the needle to the flow path formed between the sheath and the dilator. Also shown are needle openings or window holes aligned with the window holes.

FIG. 6 is an enlarged plan view illustrating another embodiment of an aligned opening or window hole in the needle and dilator.

FIG. 13B is an enlarged cross-sectional view taken along line 13B-13B in FIG. 13A and also allows the dilator opening or so as to allow fluid to flow from the inside of the needle to the flow path formed between the sheath and dilator. Also shown are needle openings or window holes aligned with the window holes.

FIG. 6 is an enlarged plan view illustrating another embodiment of a flow path formed between a dilator and a sheath.

FIG. 14B is a cross-sectional view taken along line 14B-14B in FIG. 14A and also shows the depth of the flow path extending into the sheath.

FIG. 6 is an enlarged plan view illustrating another embodiment of a flow path formed between a dilator and a sheath.

FIG. 15B is a cross-sectional view taken along line 15B-15B in FIG. 15A, and also shows the depth of the channels extending into both the dilator and the sheath.

FIG. 6 is an enlarged plan view illustrating another embodiment of a flow path formed between a dilator and a sheath.

15B is a cross-sectional view taken along line 16B-16B in FIG. 15A and also shows a plurality of equally spaced channels in the form of splines extending into the dilator.

FIG. 6 is an enlarged cross-sectional view of another embodiment of an access device, and also shows a flow path formed between a dilator having a different shape and a sheath.

FIG. 6 is a perspective view of another access device constructed in accordance with another preferred embodiment of the present invention.

FIG. 18B is an enlarged perspective view of the hub of the access device of FIG. 18A in a contracted configuration.

FIG. 19 is an enlarged perspective view of the hub of FIG. 18B in an expanded configuration.

FIG. 6 is a perspective view of an additional access device constructed in accordance with a further preferred embodiment of the present invention.

FIG. 6 is a perspective view of an additional embodiment of an access device.

  In accordance with this disclosure, an access device for delivering a medical article (eg, a catheter or sheath) to a blood vessel or drainage site is provided. FIG. 1A shows an access device 20 configured to be inserted into a blood vessel (eg, a vein or artery) according to a preferred embodiment of the present invention. The access device will be described below in this context (ie, for access to a blood vessel), but the access device may place a medical article (eg, a catheter or sheath) elsewhere in the patient's body (eg, Can be used to access and place it in the drainage site and for other purposes (eg, to drain an abscess).

  This embodiment of the access device is disclosed in the context of placing a typical single-piece, tubular medical article into a body space inside a patient. The tubular article can be used once received to receive other medical articles (eg, catheters, guidewires, etc.) to provide access into the body space and / or It can be used to introduce a fluid into the body space or provide a passage for removing (eg, draining) the fluid from the body space. In the illustrated embodiment, the tubular medical article is a sheath or catheter configured to provide a fluid pathway primarily into the vein. However, the principles of the present invention are not limited to the placement of a single member type sheath or catheter, or subsequent insertion of a medical article through the sheath or catheter. Instead, for those skilled in the art, in light of this disclosure, the access device disclosed in this specification provides a patient with a sheath, a fluid drain tube, a fluid delivery tube, and a single lumen or multiple lumen catheter. It will be understood that it can also be successfully utilized with respect to placement directly in the body of the patient or indirectly through another medical article.

  For example, the access device disclosed in this specification includes a central venous catheter, a central catheter inserted in the periphery, a hemodialysis catheter, a surgical drainage tube, a stripping sheath, a multi-component sheath, a scope Furthermore, the conductor tube for the conductor or cable connected to the external or implantable electronic device or sensor can be arranged directly or indirectly, but is not limited thereto. There is nothing. As described above, the medical articles listed above can be placed directly into the patient's body via the access device dilator, needle, and guidewire, or the access device dilator, It can then be placed in the patient's body by means of a needle and a medical article placed in the patient's body via a guide wire.

  Further, the embodiments disclosed in this specification are not limited to coaxial insertion of a single medical article. For example, two catheters can be inserted into the patient's body through the inserted sheath, or a second catheter can be inserted into the patient's body through the inserted first catheter. it can. Further, in addition to providing a conduit into a blood vessel or other body space, medical articles inserted through dilators, needles, and guidewires may be inserted into the lumen of the subsequently inserted medical article. In addition, a lumen can be formed. One skilled in the art can also find additional applications for the devices and systems disclosed in this specification. Thus, the illustration and description of an access device associated with a sheath (eg, an application for micropuncture) is merely exemplary of one possible application for this access device.

  A preferred embodiment of the access device 20 is shown in FIGS. 1A and 1B. The access device 20 includes a needle 22, a dilator 24, and a sheath 26. In the illustrated embodiment, the access device also includes a guide wire portion 28 and a channel 30. As best seen in FIG. 1B, the dilator 24 is preferably attached coaxially to the needle 22 and the sheath 26 is attached coaxially to the dilator 24. The stretch characteristics of the components of the access device are achieved by placing the components on their axes arranged substantially parallel rather than coaxial (eg, a monorail design). You can also.

  Each of these components includes a luminal joint at the end or transition (ie, hub). Thus, in the illustrated embodiment, the needle 22 includes a needle body 32 that extends distally from the needle hub 34 and the dilator 24 extends distally from the dilator hub 38. A dilator shaft 36 is included, and the sheath 26 includes a sheath body 36 that extends distally from the sheath hub 42. Guidewire portion 28 includes a guidewire 44 and preferably a guidewire hub or cap 46. In the illustrated embodiment, the guidewire hub 46 is located at the proximal end of the guidewire 44; however, in other applications, the hub 46 is at some point between the ends of the guidewire 44. May be arranged.

  2A-2G illustrate the needle body 32 and needle hub 34 of the needle 22, which are configured in accordance with a preferred embodiment of the access device, regardless of the other components of the access device 20. FIG. ing. As best seen in FIGS. 2A and 2B, the needle hub 34 is located at the proximal end of the needle body 32. Needle body 32 terminates at a distal end in the vicinity of distal portion 50 of needle 22, and needle hub 34 is at proximal portion 52 of needle 22.

  The needle body 32 preferably has an elongated tubular shape with a circular constant diameter inner hole and a circular constant diameter outer surface. However, in other embodiments, the needle body 32 has other hole shapes and outer surface shapes (such as, but not limited to, an elliptical cross-sectional shape). Also good. A groove or a flow path may be included in the inner surface or the outer surface of the needle. These grooves or channels can guide fluid within the needle hole to or around the structure of the needle 22 or within the needle 22 (eg, around a guide wire). . In some embodiments, the groove or channel may help maintain the desired orientation of the needle 22 relative to the dilator.

  Needle body 32 is long enough to access the targeted subcutaneous body space and is sufficient to withstand insertion forces without causing unnecessary trauma when approaching the body space. There are various gauge dimensions. For many applications, the needle body has a length of 3-20 cm, more preferably 3-10 cm. For example, the needle body 32 preferably has a length of 7 cm or more, more preferably 9 cm or more in order to access a body space (for example, a blood vessel) in an adult thorax, Furthermore, it is most preferred that there is a length of 9-10 cm. The above dimensions of this needle are preferably 18 gauge or less, more preferably 18-28 gauge, and more preferably 18-26 gauge for micropuncture applications (peripheral device IV). Is most preferred. For newborn applications, the length and gauge of the needle body 32 should be significantly shorter and smaller, preferably 3-4 cm and 26-28 gauge, for example.

  As best seen in FIGS. 2A and 2D, the needle body 32 includes at least one window hole or opening 56 near the distal end of the needle body 32. The window hole 56 extends through the wall of the needle body 32 and has various shapes and orientations with respect to the needle body 32, which will be described in detail below. In addition, the needle body 32 may have a beveled tip 54 disposed on the distal portion 50.

  As illustrated in FIG. 2A and FIG. 2B, at the peripheral portion around the needle hub 34 aligned with the peripheral portion of the oblique cutting portion and the peripheral portion of the opening or window hole 56 at the needle tip of the needle. The fins 58 are preferably arranged. That is, the fin 58 is indexed with respect to the oblique cut portion and the window hole. During use, a physician or health care provider can expose the bevel even when the bevel is inside the blood vessel and the window hole is covered by the sheath and / or dilator. By paying attention to the orientation of the fin 58, the orientation of the tip of the oblique cutting needle (and the window hole 56) can be determined. For example, in the illustrated embodiment, the orientation of the fin 58 away from the patient corresponds to the obliquely upward orientation of the needle tip inside the blood vessel. The window holes 56 are also on the same side as the fins 58, as can be seen in FIG. 2C.

  The fin 58 is also provided with a grip area for manual operation of the needle hub 34. For example, a physician or medical service provider can place the index finger and thumb on the side of the fin 58 to stabilize the needle hub 34 against the dilator 24 and / or the sheath 26. In the illustrated embodiment, when the dilator / sheath described above slides distally over the needle, the needle hub 34 is between the first position 121 and the second position 123 (the illustrated portion illustrated in FIG. 6A). It slides relatively along the transmission path body 30 in FIG. The fins 58 can be held when performing the insertion step (described below). In addition, the fins 58 can be used to stabilize the needle hub 34 and rotate the dilator hub 38. Furthermore, the fins 58 can be used by a doctor or medical service provider as an auxiliary instrument for grasping the access device 20 when the needle hub 34 is positioned at any position along the path 30.

  FIG. 2D is an enlarged view of a side opening or window hole 56 in the needle body 32. One or more window holes 56 provide a passage through the side of the needle body 32. The window hole 56 illustrated in FIG. 2D has an oval shape. However, the shape of the side opening 56 is not limited to that of the illustrated embodiment, and may be circular, oval, square, or other shapes.

  With particular reference now to FIGS. 2E-2G, the needle hub 34 preferably includes anchoring structures at the proximal and distal portions of the needle hub 34. These fixed structures may be luer-screw type connections or other types of connections.

  The fixation structure at the proximal portion 52 of the needle hub 34 allows a physician or medical service provider to secure another medical article to the proximal end of the needle hub 34. For example, the needle hub 34 in the illustrated embodiment includes an annular flange or lip 63. The lip 63 is threaded so that the needle hub 34 can be attached to another medical article with a corresponding luer-nut type locking feature. In addition, a physician or medical service provider can attach a syringe or monitoring fixture to the fixed structure at the proximal end to perform other procedures as desired. Needle hub 34 may also include a septum at its proximal end and / or side entry and exit if desired for a particular application.

  According to the securing structure at the distal portion of the needle hub 34, a physician or medical service provider may, for example, between the needle hub 34 and the dilator hub 38 when the needle hub 34 is in the first position 121. Needle hub 34 can be secured to dilator hub 38 to prevent relative movement. In the illustrated embodiment, the fixation structure includes a latch element 66 on the surface of the needle hub 34. The latch element 66 releasably secures the needle hub 34 to the dilator hub 38. This fixation structure allows the medical service provider to advance the needle into the patient's body and grasp the needle hub 34, dilator hub 38, or both. If desired, this fixed structure can be released, allowing relative movement between the hubs. In other embodiments, the needle hub 34 may be secured to another member of the access device, such as the sheath hub 42, or to another medical article hub, by the same or similar securing structure. Further, in some embodiments, the fixation structure can be configured to engage other medical joints such as threaded connections, luer-type connections, and the like. The fixation structure on the surface of the needle hub 34 can be modified to cooperate with various fixation structures on the surface of the dilator hub 38, sheath hub 42, or other medical article. As another example, in some embodiments, the medical article may be a catheter. As is widely understood in the art, the catheter may be provided with a generally more flexible structure compared to the sheath 26 and dilator 24. For example, in some embodiments, when inserted into a body cavity, the catheter can be safely bent at a non-twisted extreme angle to maintain an open flow path therethrough. Further, in some embodiments, the catheter is sufficient to expand a hole made by the needle or to support itself against gravity when tilting is not supported and supported by the needle. May not have sufficient structural strength.

  As described in more detail below, a guide wire 44 is introduced through the hollow portion 62 of the needle hub 34, through the needle body 32, and into the punctured blood vessel. The guide wire 44 allows the medical service provider to guide the dilator 24 and the sheath 26 into the blood vessel.

  The needle hub 34 may also include two claw portions 68 that allow the needle hub 34 to slide along the transmission path 30 between the first position 121 and the second position 123. In this preferred embodiment, the two claw portions 68 of the needle hub 34 are engaged with the feeding body 30 between the first position 121 and the second position 123, but in other embodiments, the needle hub 34. Is engaged with the path body 30 only over a part of the length of the path body 30 between the first position 121 and the second position 123. The sliding interconnection between the channel 30 and the needle hub 34 can also be accomplished using other cooperating structures (eg, corresponding ant tenon and mortise at the dovetail connection).

  FIG. 3A is a plan view of the dilator 24 of the embodiment depicted in FIG. 3B is a cross-sectional view of the dilator 24 of the embodiment depicted in FIG. 3A along line 3B-3B. As shown in FIGS. 3A and 3B, the illustrated dilator 24 includes a dilator shaft 36, a dilator hub 38, a distal region 70, and a proximal region 72. In the illustrated embodiment, the dilator shaft 36 includes side openings or window holes 74, however, in other embodiments, the dilator shaft 36 has fewer or greater numbers. A window hole 74 may be included. For example, a blood perfusion chamber or space is disposed within the dilator (described in more detail below), and the dilator shaft 36 may not include a window hole 74.

  The dilator hub 38 may have one or more drain holes. In the illustrated embodiment, this drain hole in the dilator hub 38 is formed by a groove 75. In addition, the dilator shaft 36 may include one or more longitudinal channels formed on the outer surface of the dilator shaft 36. In the illustrated embodiment, this channel is an open channel. The side walls of the open channel are formed by ridges 76. In the illustrated embodiment, the ridge 76 defines a generally smooth, arcuate outer surface that contacts the sheath 26. However, in other embodiments, the ridges may have other shapes (eg, can define a more pronounced apex). Once incorporated within the sheath body 40, the open channel in the dilator shaft 36 is closed by the inner diameter of the sheath body 40.

  FIG. 3C is an enlarged plan view of a portion of the embodiment illustrated in FIG. 3A. As described above, the illustrated dilator shaft 36 is provided with one or more openings 74 and one or more flow paths formed between the ridges 76. A side opening or window hole 74 provides a fluid passage through the side of the dilator shaft 36. The shape of the side opening 74 is not limited to the illustrated embodiment, and may be circular, oval, square, or other shapes. The opening or window hole 74 illustrated in FIG. 3C is oval.

  In the illustrated embodiment, the opening 74 in the dilator shaft 36 is oval and its major axis is non-parallel to the major axis of the oval opening 56 in the needle 22. For example, the needle opening 56 may extend in the longitudinal direction, and the dilator opening 74 may extend in the circumferential direction, or vice versa. In other words, the major axis of the dilator opening 74 is disposed generally perpendicular to the major axis of the needle opening 56. As described below with respect to additional embodiments, these openings 56, 76 have other shapes, dimensions that preferably require a significant degree of overlap to account for manufacturing tolerances and rotational misalignments. And there may be a bearing. This is why one of the window holes preferably has a dimension in at least one direction that is larger than the other one of the window holes in the same direction. Thus, in the illustrated embodiment, the needle window hole 56 has a longitudinal dimension that is longer than the longitudinal dimension of the dilator window hole 74.

  The flow path formed between the protrusions 76 extends in a proximal direction from a certain point far from the opening 74. The ridges 76 in the illustrated embodiment extend along the dilator shaft 36 and on both sides of the dilator shaft 36 to balance the dilator shaft 36 within the sheath. By balancing the dilator inside the sheath, the dilator can apply equal pressure to the inner periphery of the sheath.

  The dilator hub 38 may include anchoring structures in the proximal region 72 and the distal region of the dilator 24. Each fixing structure may be a luer-type connection part or another type of connection part. In the illustrated embodiment, the dilator hub 38 includes a first luer connection 78, a second luer connection 80, a lip 77, and a base 79. The first luer connection 78 engages the needle hub 34 on the surface of the needle 22 illustrated in FIG. 2E. The second luer connection 80 is disposed more distally than the first luer connection 78. In some embodiments, the second luer connection 80 (eg, a male luer slip connector) engages a sheath hub 42 (eg, a female luer slip connector) on the surface of the sheath 26 illustrated in FIG. 1A. Can be configured to. In addition, the male-female luer type slip connectors in these components can be reversed.

  3D is an enlarged end view of the dilator 24 of FIG. 3A. As most clearly shown in FIG. 3D, the dilator hub 38 includes a dilator hub 38 shown in FIGS. 2E-2F for securing the dilator hub 38 to the needle hub 34 when the needle hub 34 is in the first position 121. There is an opening 82 that releasably engages a latch element 66 on the surface of the needle hub 34 illustrated in FIG. Furthermore, the male-female luer type slip connectors on these dilator hubs and needle hubs 34 can be reversed in other embodiments. In embodiments where the needle hub is secured to another medical article, a similar structure can be provided on the article. For example, in some embodiments, the access device 20 may not have a dilator 24 and the needle hub 34 has a sheath hub 42 with an opening similar to the opening 82 in the dilator hub 38 as described above. Can be connected to.

  The color of the dilator 24 can be selected to facilitate contrast of the dilator 24 with blood or other fluid. For example, during blood perfusion, blood is observed to flow between the dilator 24 and the sheath to confirm proper placement of the needle in the blood vessel. In order to increase the visibility of the fluid as it flows between the sheath and the dilator 24, the sheath, together with the dilator 24, which has a color contrasting with the color of the fluid, is transparent material or transparent. It is preferably made from a material. For example, the dilator 24 can be colored white to promote its contrast to red blood. Other color expanders 24 may be employed, depending on the color of the fluid and the degree of contrast desired. Furthermore, only a portion of the dilator in the region of blood perfusion may be colored in contrast to the rest of the different colors. For embodiments where there is a flow path formed between the needle and dilator 24, the dilator 24 allows the physician to observe blood perfusion through both the sheath and the dilator 24. It can be made from a clear or transparent material similar to the sheath.

  FIG. 3E is an enlarged perspective view of another embodiment of a dilator hub 38A. The dilator hub 38A is similar to the dilator hub 38 illustrated in FIG. 3A, except that the dilator hub 38A further includes a spin nut or collar 84. The proximal end of the spin nut 84 rotates around the annular groove 73 in the dilator hub 38 (see FIG. 3A). Once placed in the annular groove 73, the spin nut 84 is prevented from moving distally in the annular groove 73, but freely rotates about the dilator hub 38A. The spin nut 84 may have an interengagement element that is secured to a corresponding interengagement element in the sheath 26. In the illustrated embodiment, the spin nut 84 includes an internal thread that engages the external thread of the sheath hub 42 in the sheath 26 illustrated in FIG. 1A.

  The dilator 24 or sheath 26 has one or more passages through which air or gas can escape or expel from between the dilator 24 and the sheath 26 and / or between the needle and the dilator. Can be formed separately or together. The one or more passages may be in the wall of the sheath 26, the sheath hub, the dilator hub 38, may be in an exposed portion of the dilator shaft, and / or the dilator 24. And may be formed between adjacent surfaces of the sheath 26. For example, FIG. 3A shows a groove 75 formed between the adjacent surfaces of the dilator 24 and the sheath 26 and disposed longitudinally. Such a discharge passage may also be a maze. These adjacent surfaces form a luer-type slip connection between the sheath 26 and the dilator 24.

  FIG. 3F is a cross-sectional view taken along line 3F-3F in FIG. 3A, and grooves that are not necessarily arranged at equal intervals around the periphery of the luer slip surface, but are arranged at equal intervals. 75. These grooves 75 are dimensioned to allow air to escape from between the dilator and the medical article such as the sheath when blood perfusion occurs. As noted above, the one or more passages need not be in the form of surface grooves 75 and may instead be in the form of openings or window holes.

  In the illustrated embodiment, the one or more passages allow air to pass through a luer-type connection between the sheath and the dilator hub. In the illustrated embodiment, the distal end of the passage 75 is disposed on the distal side of the luer connection, and the proximal end of the passage 75 is disposed on the proximal side of the luer connection.

  The one or more passages may be dimensioned to filter blood or other liquids, or include a filter or other structure that prevents the passage of liquid and allows the passage of air. May be included. For example, the sheath may itself include one or more passages in the form of small openings, pores or porous material. One or more small openings, pores or porosity in the sheath, depending on the size of the one or more passages and the expected size of the element with fluid molecules and biological characteristics (eg, red blood cells). The material can form a porous drain that allows air to pass but can retain blood.

  A method of manufacturing a dilator provided with ridges will now be described. First, an extrusion process is used to create a long tubular body with one or more longitudinal grooves or longitudinal channels on the surface of its outer diameter (OD) of the dilator or within the body of the dilator. This long tubular body exceeds the required length of a single dilator, but is preferably many times longer than the length of a single dilator. This extrusion method employs a manufacturing die with a configuration that reflects the desired configuration for the inner and outer diameters of the dilator and the depth and circumferential length of the longitudinal groove or longitudinal channel or inner channel. ing. In the illustrated embodiment of FIGS. 1-11, the long tubular body includes two longitudinal OD channels on either side of the tubular body to facilitate balance of the dilator within the sheath. It is included. However, the single flow path may be provided with a visual indication or a perfusion space for blood perfusion. These two channels preferably extend along the length of the extruded tubular body. The illustrated embodiment includes one or more channels disposed between the dilator and the sheath, but in addition or alternatively, between the needle and dilator. In addition, one or more flow paths can be formed within the dilator and / or within the sheath. Thus, in some embodiments, the dilator 24 may be constructed from a clear material, a translucent material, a transparent material, or a semi-opaque material, in order to visualize fluid perturbations within the flow path. Or the whole is manufactured.

  Returning to the illustrated embodiment, the extruded tubular body is cut to the appropriate length for a single dilator. In a preferred method, these two OD channels extend the entire length of the cut dilator.

  Thereafter, a tip processing method is employed at one end of the dilator that has been cut in order to modify the tip. One end of the cut dilator is pushed into a die / mandrel that has a configuration that matches the desired configuration of the finished dilator tip. This desired form is selected according to, for example, the inner diameter of the sheath. For the sheath and dilator, a close fitting or seal near the tip is used to enhance blood flow in the proximal direction of the flow path formed between the grooved dilator and the sheath. It is desirable to form. Preferably, the outer diameter portion of the dilator in the tip region gradually decreases in the distal direction.

  Within the die / mandrel, thermal energy is applied to the tip to modify the tip to match the die / mandrel. This thermal energy can be applied by any known technique including using radiant heat from an infrared heat source or an RF heat source. As part of this tip treatment method, the dilator in the tip region is modified so that the groove is substantially removed. When the groove is removed, the dilator can be formed with a close fitting part or a sealing part between the dilator and the sheath in the vicinity of the tip. These grooves are maintained along the remainder of the dilator on the proximal side where the sheath 26 tip is located on the surface of the dilator. After removal from the die / mandrel, the dilator tip is cleaned and cut as necessary to remove manufacturing debris.

  The one or more window holes in the dilator are created by cutting open the dilator in the vicinity of the tip region. Each window hole can be opened by any known means including a drill or a laser. Further, the ablation device can be moved relative to the dilator or the dilator can be moved relative to the ablation device to achieve an oval shape or other shape for the window hole.

  The end of the dilator opposite the tip may be widened outward to facilitate overmolding the dilator hub over the dilator.

  4A is a plan view of the sheath 26 of the embodiment depicted in FIG. 1A. 4B is a cross-sectional view of the embodiment sheath 26 depicted in FIG. 4A, taken along line 4B-4B. FIG. 4C is an enlarged proximal end view of the sheath 26 of FIG. 4A. 4D is an enlarged perspective view of the sheath hub 42 in the sheath 26 of FIG. 4A. As shown in FIGS. 4A-4D, the sheath 26 may include a sheath body 40, a sheath hub 42, a distal portion 90, and a proximal region 92. The sheath body 40 can be partially or wholly manufactured from a clear material, a translucent material, a transparent material, or a semi-opaque material. The sheath body 40 may also include one or more radiopaque markers such as, for example, barium sulfate stripes. In a preferred embodiment, the sheath includes two such radiopaque stripes that are placed in contrast on either side of the body 40.

  The sheath body 40 may be a single member sheath through which a catheter or other medical article (eg, a guide wire) is inserted into a blood vessel. In such embodiments, the sheath body 40 forms a conduit for insertion of a catheter or other medical article (eg, a guide wire). In addition to providing a conduit, a lumen that joins the lumen of the catheter can be formed in the sheath or part of the sheath. For example, the equivalent of a triple lumen catheter can be formed by inserting a double catheter through the sheath body 40, which itself forms the third lumen.

  Depending on the type of catheter or medical article that is inserted into the blood vessel after employing the access device 20, it may be advantageous to remove some or all of the sheath body 40. For example, after a catheter or other medical article has been inserted into the blood vessel, a portion of the sheath body 40 can be separated or peeled away. The stripping sheath includes punched holes, serrations, saw edges, or other structures so that a physician or medical service provider can easily remove some or all of the sheath body 40. Alternatively, other materials (for example, bismuth-containing PTFE) may be included.

  The sheath hub 42 may include a luer-type slip connection part and a fixing member 94. The fixing member 94 may include a fixing or attachment structure that meshes with or engages with a corresponding structure. For example, the securing member 94 may be a luer connection 94 that can be configured to engage the second luer connection 80 of the dilator hub 38.

  The sheath hub 42, as best seen in FIGS. 4C and 4D, allows the dilator hub 38 locking mechanism or the second luer connection 80 to enter the sheath hub 42 without substantial obstruction. Are preferably designed. However, in use, once the sheath hub 53 is positioned at a desired location across the dilator shaft 36, the physician or medical service provider can push, pull or twist the sheath hub 42 to separate it from the securing member 94. The corresponding connector in the medical article can be disengaged or engaged as much as possible. For example, the securing member 94 may be a luer connection, protruding hump, indentation, etc. that creates a mechanical fit such that the dilator hub 38 and the sheath hub 42 are releasably interconnected. In the illustrated embodiment, the securing member 94 of the sheath hub 42 is provided with a luer connection. The sheath hub 42 preferably engages a corresponding second luer connection 80 in the dilator hub 38. Preferably, the securing point can be disengaged or engaged by pulling, squeezing, pushing, or twisting the dilator hub 38 against the sheath hub 42. .

  In some embodiments, the sheath hub 42 includes a lip 95. The lip 95 may be threaded so that the sheath hub 42 can be attached to other medical articles that have corresponding locking features.

  The sheath hub 42 has one or more characteristic surface configurations so that a physician or medical service provider can easily grasp or manually manipulate the sheath 26 and / or the access device 20. preferable. In the illustrated embodiment, the sheath hub 42 includes a square grip 96 and a ridge 98.

  In additional embodiments, the sheath hub 42 includes a radially extending wing or handle structure so that the sheath hub 42 can be easily removed and removed from other articles of the access device 20. Yes. In some applications, these wings are dimensioned to provide a medical service provider with a leverage to break apart the sheath hub 42. For example, the sheath hub 42 may be provided with a thin film for connecting the halves of the sheath hub 42 to each other. The membrane is dimensioned to keep the halves of the sheath hub 42 away from each other until the medical service provider decides to remove the sheath hub 42 from the access device. The medical service provider manually operates the wing portion to break the membrane and separate the sheath hub 42 into the removable half.

  FIG. 5A is a perspective view of the guidewire portion 28 of the embodiment depicted in FIG. 1A. FIG. 5B is a plan view of the guidewire portion 28 of the embodiment depicted in FIG. 5A, which preferably includes a guidewire hub 46. The guidewire hub 46 has one or more characteristic surface configurations so that a physician or medical service provider can easily grasp or manually operate the guidewire hub 46 and / or the access device 20. It may be. In the illustrated embodiment, the guidewire hub 46 is provided with one or more ridges 110. In the pre-loaded state, the outer surface of the guide wire hub 46 is fixed to the fixing mechanism 130 in the transmission body 30 when the guide wire hub 46 is in the third position 125 (for example, the third position 125 illustrated in FIG. 6A). Is engaged.

  In some embodiments, the guidewire 44 can form a tight fit with the inner diameter of the needle body to provide a self-suction function when retracted. For example, the outer diameter of the guide wire 44 may be selected to form a tight fit with the needle along the length of the guide wire or along only a portion of the guide wire 44. it can.

  In some embodiments, the distal end portion of the guidewire may have a reduced diameter relative to other portions of the guidewire. Such a reduced diameter dimension is such that fluid can move into the window hole 56 in the needle body even when the guidewire is advanced beyond the distal tip of the needle. Can be selected.

  FIG. 6A is a perspective view of the channel 30 of the embodiment depicted in FIG. 1A. FIG. 6B is a plan view of the transmission path body 30 illustrated in FIG. 6A. FIG. 6C is a side view of the transmission path 30 illustrated in FIG. 6A. 6A-6C, the channel 30 in the illustrated embodiment includes a distal portion 120, a proximal portion 122, and a distal anchor that connects the channel to the dilator hub 38. Member 124, a locking mechanism 128 that prevents further distal and proximal movement of needle hub 34 when needle hub 34 slides along path 30 from first position 121 to second position 123, and guide A fixing mechanism 130 is provided that can attach the guide wire hub 46 to the transmission body 30 when the wire hub 46 is in the pre-loaded state or at the third position 125. This channel is preferably made from a polycarbonate material. However, other materials can be used as described below.

  The channel 30 may further include a channel segment 132 with a reduced width, as best shown in FIGS. 6A and 6B. This reduced width makes it easier to assemble the needle hub to the path 30. The illustrated embodiment includes a rib 133 at the distal portion 120 of the channel 30. This rib 133 provides additional structural reinforcement between the distal fixation member 124 and the remainder of the channel 30.

  As illustrated in FIG. 1A, the distal fixation member 124 is connected to the dilator 24 and allows the channel 30 to extend distally from the dilator 24. For example, the securing member 124 may consist of two curved arms 124 connected to the dilator hub 38 between the lip 77 of the dilator hub 38 and the base 79 of the dilator hub 38. The securing member 124 restricts movement of the channel 30 in the distal or proximal direction relative to the dilator hub 38, but the channel 30 rotates freely about the dilator hub 38. be able to.

  FIG. 6D is an enlarged view of a portion of the embodiment depicted in FIG. 6B. As shown, the fixing mechanism 128 is formed by changing the width of the path body in the region of the second position 123. For example, the illustrated embodiment includes a channel portion 134 having an increased width in the distal direction, and a channel portion having a decreased width at the distal end of the channel portion 134 having an increased width. 136 and two finger elements 138 are included. These two finger elements 138 protrude from the distal end of the channel body portion 136 toward the proximal end of the channel body 30 and extend outward from the longitudinal axis of the channel body 30.

  FIG. 6E is an enlarged view of a portion of the embodiment depicted in FIG. 6B. The fixing mechanism 130 is formed by a clip, clasp or other structure that engages a part of the guide wire hub or a part of the transmission body 30 when the guide wire hub is in the third position. ing. Some or all of the engagement structures may be members of the path body 30, may be members of the guide wire hub, or may be between the path body 30 and the guide wire hub. It may be divided. In the illustrated embodiment, the fixing mechanism 130 extends from the transmission path 30 and engages with the guide wire hub. The fixing mechanism 130 includes a rectangular element 140 projecting from the path body 30, two path body arms 142 projecting from the path body 30 to the distal side of the rectangular element 140, and a path body from the path body 30. A stop 144 is provided that projects distally of the arm 142.

  In the illustrated embodiment, the locking mechanism between the needle hub and the dilator is on the proximal side of the dilator hub. However, in other embodiments, the securing mechanism can be similarly disposed at other locations. For example, when the locking mechanism includes two pivoting levers joined by a locking hinge, the locking mechanism can be arranged radially with respect to the needle hub. In such an embodiment, one lever is pivotally connected to the dilator and the other lever is pivotally connected to the needle. As the needle hub moves away from the dilator hub, the levers straighten toward where the hinge is secured. A similar effect can be obtained with a tether that restricts proximal movement beyond a specific point of the needle hub relative to the dilator, thereby securing these components together. In yet another embodiment, the elongated structure may extend from the needle hub parallel to the needle body within the dilator. Once the needle hub has moved a sufficient distance from the dilator, an additional structure (eg, detent) of the locking mechanism engages the elongated structure to prevent further movement of the needle relative to the dilator. Is done. Thus, as illustrated by these three additional embodiments, the locking mechanism that operates between the needle and the dilator can be located at various locations relative to the dilator hub.

  FIG. 7A is an enlarged plan view of the access device of the embodiment depicted in FIG. 1A preloaded with a guide wire. FIG. 7B is a side view of the embodiment depicted in FIG. 7A. FIG. 7C is a cross-sectional view of the embodiment depicted in FIG. 7A along line 7C-7C. FIG. 7D is a proximal end view of the access device 20 of FIG. 7A. In this pre-mounted state, the guide wire hub 46 is fixed to the transmission body 30 when the guide wire hub 46 is disposed at the third position 125. In this position, the guidewire hub 46 can be secured to the transmission body 30 between the rectangular element 140 and the stop 144. For example, the guidewire hub 46 can be releasably secured between the rectangular element 140 and the stop 144. In addition, the path body arm 142 can further secure the guide wire hub 46 to the path body 30. According to this fixing mechanism, when the guide wire hub 46 is in the third position 125, unintended rotational movement and axial movement of the guide wire 44 in at least the distal direction can be prevented. Of course, the medical service provider may disengage the guidewire hub 46 from the channel 30 to allow distal movement of the guidewire across the access device 20.

  In the preloaded state illustrated in FIGS. 7A-7C, the needle hub 34 is secured to the dilator hub 38 when the needle hub 34 is in the first position 121. Preferably, in this fixed position, the openings or window holes in the needle and dilator are aligned or aligned with each other. When needle 22 and dilator 24 are secured, unintentional rotational and axial movement with respect to each other is at least somewhat prevented. By preventing unintentional rotation of the dilator hub relative to the needle 34, the window holes or openings are maintained in their overall alignment.

  In this pre-loaded state, the dilator hub 38 is fixed to the sheath hub 42. This prevents at least some unintentional rotational and axial movement between the dilator 24 and the sheath 26. When the sheath hub 42 and dilator 24 have only a luer-type slip connection, the dilator 24 and the sheath hub 42 can rotate relative to each other.

  FIG. 8A is a plan view of the embodiment depicted in FIG. 1A illustrating the operational steps of one method using the access device 20. 8A depicts the needle body 32 of the access device 20 inserted into a blood vessel 148, such as a vein. Although the described method refers to vascular access, the access device 20 may access other locations within the patient's body (eg, locations for abscess drainage) and catheters therein. Alternatively, it can be used for positioning the sheath and for other purposes.

  FIG. 8B is an enlarged plan view of the portion surrounded by line 8B-8B in the embodiment illustrated in FIG. 8A. FIG. 8C is an enlarged plan view of the portion surrounded by the line 8C-8C of the embodiment depicted in FIG. 8B. FIG. 8D is an enlarged cross-sectional view of the embodiment depicted in FIG. 8C, taken along line 8D-8D.

As described above, the needle body 32 has one or more side openings 56 on its side walls. The dilator shaft 36 has one or more side openings 74. These side openings 56, 74 may have the same or different shapes and aspect ratios. In the illustrated embodiment, the side opening 56 in the needle body 32 has a different aspect ratio than the side opening 74 in the dilator shaft 36. The side opening 56 in the needle body 32 is elongated in one direction (for example, a direction substantially parallel to the longitudinal axis of the needle body 32). The side openings 74 in the dilator shaft 36 are elongated in different directions (eg, along the circumference of the dilator shaft 36). Because there are offset elongated openings 56, 74 in the needle body 32 and dilator shaft 36, the openings 56, 74 in the needle body 32 and dilator shaft 36 are well aligned so that blood can pass through the needle side openings 56. And the possibility of flowing through the dilator side opening 57 is increased. 8A-D illustrate the alignment between only one set of corresponding side openings. Other sets of these side openings also depend on the relative orientation of the needle body 32 and the dilator shaft 36, but can be aligned or unaligned.

  In the illustrated embodiment, the dilator shaft 36 is coaxially disposed to minimize the annular space 150 between the needle body 32 and the dilator shaft 36. The inner surface 152 of the dilator shaft 36 need not be in direct contact with the outer surface 154 of the needle body 32, although it is possible. Preferably, in this embodiment, the annular space 150 between the outer surface 154 of the needle body 32 and the inner surface 152 of the dilator shaft 36 is minimized, and between the dilator shaft 36 and the needle body 32. The flow of blood or its components (or other body fluids) into the annular space 150 is blocked. Advantageously, this characteristic configuration minimizes blood contact to multiple exterior surfaces and reduces the risk of contamination, infection, and clotting.

  As illustrated in FIG. 8A, the dilator shaft 36 is rotationally aligned with at least a portion of one side opening 56 provided in the needle body 32 to one side opening 74 in the dilator shaft 36. Thus, it is attached to the needle body 32 coaxially. Preferably, needle body 32 and dilator shaft 36 maintain rotational alignment so that blood flows through needle side opening 56 and dilator side opening 74.

  As previously described, the sheath body 40 is preferably partially or wholly made from a clear material, a semi-opaque material, a translucent material, or a transparent material, so that blood As it flows (1) through the needle side opening 56, (2) through the dilator side opening 74, and (3) into the flow path 156, the physician or health care provider can see the blood. In some aspects, the flow path 156 is formed between the dilator shaft 36 and the sheath body 40 and is defined by one or more ridges 76 in the dilator shaft 36. In some aspects, the flow path 156 is formed within the wall of the dilator shaft 36, and the dilator shaft 36 is preferably constructed from a transparent material. The blood informs the doctor or medical service provider that the beveled tip 54 of the needle body 32 has punctured the blood vessel 148.

  In some embodiments, needle body 32 and dilator shaft 36 (both) have multiple side openings, where some or all of these side openings can be rotationally aligned. .

  The channel 156 has an axial length that is substantially the same as the length of the sheath 26. In other embodiments, the channel 156 may be significantly shorter than the elongated channel 156. For example, the channel 156 may be disposed within the distal portion, intermediate portion, and / or proximal portion of the sheath 26, but is not limited thereto. Alternatively, the channel 156 may be linear, curved or helical along the axial length of the sheath 26, or may be formed by a plurality of such shapes. The flow path 156 may have various depths and span angles. The depth of the flow path 156 may be in a range from a value almost close to 0 to 0.010 inches. Preferably, the flow path 156 has a depth of about 0.0005 inches to about 0.003 inches. Even more preferred is that channel 156 has a depth of about 0.001 inch to about 0.002 inch. The flow path 156 may have a span angle Φ of about 30 degrees to about 210 degrees or more with respect to the axis of the dilator 24, but preferably less than 360 degrees. Even more preferred is that the flow path 156 has a span angle Φ of about 60-150 degrees. These depths and span angles Φ can be selected to optimize the capillary action that occurs inside the flow path 156 when fluid (eg, whole blood) enters the flow path 156, and in the body cavity Further selections can be made based on the expected pressure and the viscosity of the liquid.

  8E-8G show how fast the fluid is when the span angle is 120 degrees, the contact angle (θ) is 5 degrees, and the circumferential length (H) is 60 degrees and 0.64 mm. It is a graph of the test data which illustrates whether it is pulled up to the surface of the flow path 156. In each graph, the fill length (mm) is plotted on the y-axis and the time (seconds) is plotted on the x-axis. These tests were performed at hydrodynamic pressures similar to those experienced by peripheral blood vessels. FIG. 8E illustrates the rate at which fluid is pulled up to 0.002 inch gap height channel 156 and FIG. 8F illustrates fluid 0.001 inch gap height channel 156. FIG. 8G illustrates the speed at which the fluid is pulled up to the flow path 156 with a gap height width of 0.0005 inches. As shown in FIGS. 8E-G, fluid is drawn up fastest in a channel with a gap height of 0.0005 inches, and then fast in a channel with a gap height of 0.001 inches. Next, it is quickly pulled up in a flow path having a gap height width of 0.002 inches.

  The shape of the channel 156 and the resulting capillary action are optimized for use with whole blood as against other fluids (eg, white blood cells, pus, urine, plasma) that have a different viscosity than whole blood. It was done. However, the shape of the channel 156 is not limited to the disclosed shape and can be optimized to drain other liquids such as pus. Furthermore, the shape of the flow path 156 is because of the blood vessels located in the periphery where the capillary action and the resulting blood perfusion are promoted by the pressure in the blood vessels, and because of the blood vessels located in the low pressure region. Optimized for. For example, in the thoracic region of the body, the expected pressure in the vein will be lower than that in the peripherally located vein when the patient breathes. Channels of different dimensions for use of the access device 20 in other areas of the body can be employed taking into account the expected pressure within the blood vessel or body cavity.

  In addition, the outer surface 160 of the dilator shaft 36 and / or the inner surface 158 of the sheath body 40 can be coated with a material that promotes or increases capillary action within the flow path 156. For example, a hydrophilic material can be used to coat the outer surface 160 of the dilator shaft 36 and / or the inner surface 158 of the sheath body 40 to increase capillary action. Similarly, one or both of these components can be made from a hydrophilic material. A hydrophilic material can be applied to the outer surface of the sheath 26 to act as a lubricant for easy insertion of the sheath 26 into the patient's body. Other lubricants or lubricious coatings can be used on the outer surface of the sheath 26, or at least the outer surface of the sheath can be formed from a lubricious material. In addition, the sheath 26 can be coated or formed with a substance (eg, heparin) that elutes from the sheath to increase the clinical use of the access device 20.

  FIG. 8H is a cross-sectional view of the embodiment depicted in FIG. 8C taken along line 8H-8H. In this region of the illustrated access device 20, the sheath body 40 minimizes the annular space 157 between the sheath body 40 and the dilator shaft 36 and provides relative movement between the sheath body 40 and the dilator shaft 36. It is arranged coaxially to make it possible. The inner surface 158 of the sheath body 40 need not be in direct contact with the outer surface 160 of the dilator shaft 36, although this is possible. An annular interface 157 between the outer surface 160 of the dilator shaft 36 and the inner surface 158 of the sheath body 40 allows blood or components thereof (or other body fluids) to flow distally from the opening 74 in the dilator shaft 36. In order to prevent this, it may be reduced in this region.

  FIG. 8I is an enlarged plan view of the portion surrounded by the line 8I-8I in the embodiment illustrated in FIG. 8A. FIG. 8J is a cross-sectional view of the embodiment depicted in FIG. 8I. FIGS. 8I and 8J illustrate the needle hub 34 secured to the dilator hub 38 when the needle hub 34 is in the first position 121. The dilator shaft 36 can be mounted coaxially by sliding the hollow portion 84 of the dilator shaft 36 into the needle body 32 and removably securing the dilator hub 38 to the needle hub 34. The proximal end 86 of the dilator hub 38 is configured to mechanically fit and interconnect with the needle hub 34.

  The dilator shaft 36 is mounted so that the dilator shaft 36 can be attached to and removed from the coaxial position relative to the needle body 32, or the needle body 32 is attached to the coaxial position relative to the dilator shaft 36. And can be removably attached to the needle body 32 so that it can be removed from the coaxial position. According to this securing mechanism, at least some unintended rotational movement and axial movement between the needle 22 and the dilator 24 can be prevented when the needle hub 34 is in the first position. As shown, the needle hub 34 may have a luer connection 64 that is secured to the luer connection 78 of the dilator hub 38. Furthermore, the needle hub 34 may further include a latch element 66 that is secured to the opening 82 in the dilator hub 38.

  In addition, FIGS. 8I and 8J illustrate the dilator hub 38 engaged with the sheath hub 42 when the access device 20 is inserted into the blood vessel 148. Preferably, the proximal end 86 of the sheath hub 42 is configured to mechanically fit and removably engage the dilator hub 38. As shown, the luer connection 80 in the dilator hub 38 can engage the sheath hub securing member 94. The resulting frictional fit can at least partially prevent unintended rotational and axial movement between the dilator 24 and the sheath 26 when the access device 20 is inserted into the blood vessel 148.

  FIG. 9A is a side view of the embodiment depicted in FIG. 1A illustrating further operational steps of the access device 20. FIG. 9A illustrates the guidewire 44 of the access device 20 advanced distally into the blood vessel 148. This can be achieved by advancing the guidewire hub 46 distally from the third position 125. The guidewire hub 46 is then secured to the needle hub 34 when the needle hub 34 is in the first position 121.

  FIG. 9B is an enlarged side view of the portion surrounded by the line 9B-9B of the embodiment illustrated in FIG. 9A. FIG. 9C is a cross-sectional view of the embodiment depicted in FIG. 9B. FIG. 9C illustrates the locking mechanism between the guidewire hub 46 and the needle hub 34. Preferably, the guidewire hub 46 is mechanically fitted to the needle hub 34 and is removably or irreversibly interconnected thereto. As shown, the guidewire hub 46 includes a hump 162 on the inner surface of the guidewire hub 46. The guidewire hub hump 162 is moved over the needle hub 34 by advancing the guidewire hub 46 distally until the hump 162 is secured within the threaded groove in the lip of the needle hub 34. Can be fixed to. In other embodiments, the guidewire hub 46 can be secured to the needle hub 34 via corresponding threaded elements.

  FIG. 10A is a side view of the embodiment depicted in FIG. 1A and illustrates yet another operational step of the access device 20. FIG. 10A depicts the dilator shaft 36 and sheath body 40 advanced distally into the blood vessel 148. This is accomplished by removing the dilator hub 38 from the needle hub 34 and advancing the dilator 24 and sheath 26 distally relative to the needle hub 34 along the guidewire and needle described above. Can do. FIG. 10A further illustrates the proximal movement of needle 22 and guidewire portion 28 relative to dilator 24 and sheath 26. Needle hub 34 will be secured to channel 30 when needle hub 34 reaches second position 123.

  FIG. 10B is an enlarged rear view of the portion of the embodiment depicted in FIG. 10A surrounded by line 10B-10B. As depicted in FIG. 10B, the needle hub 34 is fixed on the transmission path 30 via the fixing mechanism 128 at the second position 123. The needle hub pawl 68 slides proximally over the channel finger 138 and the pawl 68 is between the channel finger 138 and the increasing width channel portion 134. Can be fixed in This prevents axial movement of the needle body 32 at least in the distal direction when the needle hub 34 is in the second position 123, and more preferably prevents it substantially irreversibly. In the illustrated embodiment, the locking mechanism 128 irreversibly prevents the needle hub 34 from moving either proximally or distally once engaged. Furthermore, the distal tip 54 of the needle 22 is withdrawn into the dilator 24 to retract the distal tip 54 when the needle hub 34 is in the second position 123. Thus, according to this locking mechanism 128, once the dilator shaft 36 is advanced over the needle body 32 during use, the beveled tip 54 disposed at the distal portion 50 of the needle body 32 causes the distal end of the dilator shaft 36 to Advancing past the top edge is prevented. Accordingly, the dilator shaft 36 stores the sharp beveled tip 54 of the needle body 32 in the sheath, thereby preventing the occurrence of accidental needle sticks.

  FIG. 11A is a side view of the embodiment depicted in FIG. 1A illustrating the final operating steps of the access device 20. FIG. 11A illustrates removal of the guide wire 44 and dilator shaft 36 from the vessel leaving the sheath body 40 properly inserted within the vessel 148. FIG. 11B is an enlarged plan view of a portion surrounded by a line 11B-11B in the embodiment illustrated in FIG. 11A. As clearly shown in FIG. 11B, the distal end of the dilator shaft 36 and the guide wire 44 extend beyond the sharp beveled tip 54 of the needle body 32, causing inadvertent needle punctures to occur. Be blocked.

  As described above, the different aspect ratio openings 56, 74 in the needle body 32 and dilator shaft 36 cause the openings 56, 74 in the needle body 32 and dilator shaft 36 to be aligned and blood. Increases the likelihood of flowing through the needle side opening 56 and the dilator side opening 74 without being substantially impeded.

  In some embodiments below, structures that are similar to structures from one embodiment that are similar to structures from another embodiment have the same basic reference number, including subscripts that are specific to each embodiment. (32, 32A, 32B, etc.). 12A is a plan view of another embodiment of the openings 56, 74 in the needle body 32 and dilator shaft 36 illustrated in FIGS. 8B and 8C. 12B is an enlarged cross-sectional view of the embodiment depicted in FIG. 12A, taken along line 12B-12B. 12A and 12B depict a needle body 32A with an oval opening 56A and a dilator shaft 36A with a circular opening 74A. In other embodiments, the needle may have a circular opening and the dilator may have an oval opening. These embodiments increase the likelihood that the openings 56A, 74A are at least substantially aligned so that blood flows through the needle side opening 56A and the dilator side opening 74A.

  FIG. 13A is a plan view of another embodiment of openings 56, 74 in needle body 32 and dilator shaft 36 illustrated in FIGS. 8B and 8C. FIG. 13B is an enlarged cross-sectional view of the embodiment depicted in FIG. 13A along line 13B-13B. 13A and 13B depict a needle body 32B with a circular opening 56B and a dilator shaft 36B with a circular opening 74B that is larger than the circular opening 56B in the needle body 32B. In other embodiments, the opening in the dilator may be smaller than the opening in the needle. According to these embodiments, the possibility that the openings 56B, 74B are at least substantially aligned is also increased such that blood flows through the needle side opening 56B and the dilator side opening 74B.

  As described above, the dilator shaft 36 is formed with a conduit or channel between the sheath body 40 and the dilator shaft 36 so that the beveled tip 54 of the needle body 32 punctures the blood vessel appropriately. There may be one or more channels 156 formed between the ridges 76 to allow the doctor or medical service provider to observe the blood after the Without extrusion, but by extruding various possible configurations of axial indentations, or by forming a well-confined channel within the dilator shaft or the needle body , May be formed.

  14A is a plan view of another embodiment of the ridge 76 depicted in FIG. 8C. 14B is an enlarged cross-sectional view of another embodiment of the ridge 76 depicted in FIG. 8D. 14A and 14B depict two ridges 76C on the inner surface 158C of the sheath body 40C that form at least one flow path 156C between the sheath body 40C and the dilator shaft 36C.

  FIG. 15A is a plan view of another embodiment of the ridge 76 depicted in FIG. 8C. FIG. 15B is an enlarged cross-sectional view of another embodiment of the ridge 76 depicted in FIG. 8D. 15A and 15B show two ridges 76D on the inner surface 158D of the sheath body 40D that are combined to form a flow path 156D between the sheath body 40D and the dilator shaft 36D, and the dilator shaft 36D. Two protrusions 76E on the outer surface 160D are depicted. For example, when the desired flow path depth is about 0.001 inch, the two ridges 76D on the inner surface 158D of the sheath body 40D are each about 0.0005 inch high and the dilator shaft 36D. Each of the two ridges 76E on the outer surface 160D is about 0.0005 inches high.

  FIG. 16A is a plan view of another embodiment of the ridge 76 depicted in FIG. 8C. 16B is an enlarged cross-sectional view of another embodiment of the ridge 76 depicted in FIG. 8D. 16A and 16B depict many ridges on the outer surface 160E of the dilator shaft 36E. A spline 76F is provided between the adjacent ridges. A plurality of flow paths 156E are formed between the sheath body 40 and the dilator shaft 36E by these splines 76F. One or more of these flow paths 156E may have the same span angle Φ or different span angles Φ. In the illustrated embodiment, the flow path 156E has a span angle Φ of 120 degrees and 23 degrees. In another embodiment, one ridge 76 may be helical around the outer surface of the dilator along its length.

  FIG. 17 is an enlarged cross-sectional view of another embodiment of an access device, and shows a flow path 156F formed between a medical article or sheath body 40F having a different shape and a dilator shaft 36F. . In the illustrated embodiment, the outer surface of the dilator shaft 36F has an oval shape and the inner surface of the sheath body 40F has a circular shape. One or more flow paths or gaps 156F are formed between the sheath body 40F and the dilator shaft 36F by the oval dilator shaft 36F and the adjacent circular sheath body 40F. Of course, the shapes of the sheath body 40F and dilator shaft 36F are not limited to circular and oval shapes, and include any other combination of different shapes in adjacent regions of the sheath body 40F and dilator shaft 36F. be able to. In some aspects, the outer surface of the dilator shaft 36F is oval and the inner surface of the sheath body or medical article 40F is circular. In some aspects, the outer surface of the dilator shaft 36F is circular and the inner surface of the medical article 40F is square. The gap or channel 156F may follow the longitudinal axis, and may be in a spiral path along the longitudinal axis, a linear path along the longitudinal axis, or other path along the access device. It may follow. In some embodiments, the linear passage is parallel to the longitudinal axis. The depth of the gap or channel 156F may vary along at least a portion of the length of the gap or channel 156F.

  In other embodiments, the channel 156 can be formed by providing one complete ridge on the inner surface of the sheath and one complete ridge on the outer surface of the dilator. In another embodiment, the inner surface of the sheath has two ridges that extend for 50% of the length of the channel 156, and the outer surface of the dilator extends for the remaining 50% of the channel 156. There may be two ridges to issue.

  FIG. 18A is a perspective view of another preferred embodiment of the access device 20 '. As shown, the sheath hub 42 ′ includes a variable volume space such as the flexible hollow body 200. In other embodiments, this variable volume space, such as a flexible hollow body, can be located on the surface of another hub, such as dilator hub 38 or needle hub 34. For example, in some embodiments, as described herein, a perfusion chamber or space in a manner similar to that used to create a space between the dilator shaft and the sheath body. Can be provided between the dilator shaft and the needle body. Some examples of the space between the needle body and the dilator shaft include International Publication No. WO2009 / 114837 (issued September 17, 2009 and incorporated herein by reference in its entirety. 18A-18C and related text are included. Similarly, in some embodiments, a torsion chamber or space is provided between the needle body and the sheath body, such as when the dilator is not present, or when the sheath also functions as its own dilator. Can be provided. More generally, a perfusion chamber or space can be provided in any portion between the outer surface of the needle body and the inner surface of a medical article attached directly or indirectly to the needle body. The flexible hollow body 200 has at least one flexible wall that changes the volume inside the space, but the variable volume space has two or more components that move relative to each other (eg, Can be defined between the piston-cylinder arrangement.

  As depicted in FIGS. 18B and 18C, the flexible hollow body 200 may have a hemispherical shape, but in other embodiments it may be generally rectangular, pyramidal, or other shapes. There may be different shapes. The depicted flexible hollow body 200 extends laterally from the sheath hub 42 'and communicates with a hub opening 205 in the sheath hub. The hub opening 205 causes the flexible hollow body 200 to enter a fluid perturbation space such as the flow path or generally annular space between the sheath body 40 and the dilator shaft 36 as described herein. Can communicate. In other embodiments, a similar flexible hollow body can be disposed, for example, on the surface of the dilator hub 38 or the needle hub and the annular space between the dilator shaft 36 and the needle body 32 or It can be made to communicate with a flow path. For example, in some embodiments, a torsion space can be disposed between the needle body 32 and the dilator shaft 36 and a flexible hollow body as described herein is in communication therewith. Can do. In such embodiments, the side window holes in the dilator shaft 36 can be omitted while maintaining a substantially similar function. In yet another embodiment, the flexible hollow body 200 communicates with any of the other spaces described herein or similar spaces that are in direct or indirect communication with the needle tip. Can be made. The variable volume chamber may be disposed between the hubs or in front of the hubs.

  As depicted in FIG. 18B, the flexible hollow body 200 is initially contracted. Typically, a human hand may hold the hollow body in a contracted state by depressing the flexible hollow body 200 and holding it in a compressed position, or by some other means. it can. However, in other embodiments, it can be held in a contracted state by a mechanical contraction mechanism integrated with other grip portions of the access device 20 '. In some preferred embodiments, the flexible hollow body 200 is positioned and configured such that the flexible hollow body is also contracted by the hand holding the access device 20 ′ with the sheath hub 42 ′. Can do. Similarly, in embodiments where the flexible hollow body 200 is on the surface of a dilator hub or needle hub, the flexible hollow body is also flexible by the hand holding the device with the hub. It can be configured such that the hollow body contracts.

  When the flexible hollow body 200 enters the patient's body, it can be released and freely expanded (as depicted in FIG. 18C). To achieve this objective, the flexible hollow body 200 is naturally or forced to be directed to this expansion device when released. Outside the patient's body, this will cause the flexible hollow body 200 of the depicted embodiment to fill with air passing through the needle body 32. However, when the flexible hollow body 200 is released in a contracted state while it is in the patient's body, the released hollow body when the needle 32 enters a fluid filling a body space such as a vein. The negative pressure created by the fluid facilitates the uptake of bodily fluids, as will be explained further below.

  The uptake of bodily fluids such as blood flow may be accelerated or prevented by the frictional resistance associated with the access device 20 'and the pressure inside the access device 20'. Furthermore, uptake may increase with the pressure of the associated fluid. In some embodiments, the resistance and negative pressure from the contracted flexible hollow body 200 is satisfied when the flexible hollow body enters the blood vessel, but the general enveloped tissue. Can be selected so that it is not satisfied. The addition of negative pressure can facilitate the uptake of body fluids even from lower pressure environments such as the central vein. In an alternative embodiment, the resulting negative pressure may be selected to direct uptake from other blood vessels, such as arteries, where there is a higher blood pressure and thus a smaller negative pressure can be utilized. it can. As described further below, in some embodiments, the surgeon can select the magnitude of the resulting negative pressure during surgery.

  In order to maintain the negative pressure, the variable volume chamber and the space with which it communicates can be sealed from the ambient atmosphere. For example, the sheath hub 42 'may include or engage a sealing material such as an O-ring, a Bodok seal, a gasket, or other flexible non-porous material. Good. Thus, this sealing member can prevent gas permeation between the sheath hub 42 'and another part of the access device 20', such as a dilator hub. In other embodiments, the sealing member can be provided between other components described in this specification. Further, in some embodiments, a sealing member can be provided between the sheath body 40, the dilator shaft 36, and / or the needle body 32. For example, the sheath body 40 and the dilator shaft 36 can be sized in at least one part to create a seal when the sheath body is attached to the surface of the dilator shaft. Similarly, the dilator shaft 36 and the needle body 32 can be sized in at least a portion to create a seal when the dilator shaft is attached to the sheath body.

  Thus, in surgery, the flexible hollow body 200 can be initially contracted outside the patient's body. As the access device 20 'enters the patient's body, the flexible hollow body 200 is released, creating a negative pressure that tends to draw fluid into the access device 20'. As the flexible hollow body 200 enters the blood vessel, blood is drawn into the access device 20 ′ and air is pushed away into the flexible hollow body 200 by the blood. Can be extended. The added negative pressure from the flexible hollow body 200 accelerates the uptake of blood into the access device 20 '. When the access device 20 'includes, for example, a transparent sheath, the operator of the access device 20' can receive a faster indication of venous entry.

  FIG. 19 is a perspective view of another preferred embodiment of an access device constructed in accordance with the present invention. As shown, instead of the flexible hollow body 200 directly connected to the sheath hub 42 ′, the sheath hub 42 ″ can be attached to a tube 210 that extends to the pump 215. This tube 210 can be connected to the sheath hub 42 'via a one-way valve 220 (eg, to prevent infusion of air into the patient's body). Similarly, the pump 215 can communicate with ambient air via a one-way valve 225. Thus, the pump 215 provides a negative pressure similar to that described for the flexible hollow body 200. In addition, the tube 210 can be connected to other parts of the access device 20 ″ as discussed with respect to the flexible hollow body 200, as with a dilator hub or needle hub. In some embodiments, the negative pressure can be provided by a syringe instead of or in addition to pump 215. As discussed above, various sealing members may include an access device 20 ″ such as valves 220, 225.

  It will be apparent from the description in this specification that the embodiment in FIG. 18 and the embodiment in FIG. 19 may be combined. For example, in some embodiments, the flexible hollow body 200 and the pump 215 can be combined to create an increased negative pressure. Other embodiments may include multiple variable volume chambers of the same or different types. Conveniently, in those embodiments with multiple chambers, the surgeon can select the degree of negative pressure to apply by deflating a particular set of chambers. For example, in one embodiment, two chambers can have different associated negative pressures. Larger chambers can be deflated when the operator desires an indication of entry into a low pressure vessel such as a vein, and smaller chambers are intended for high pressure vessels such as arteries. Can do. In addition or alternatively, the chamber can be configured for the negative pressure required in the neonatal artery or vein. In yet another embodiment, multiple chambers can be run at once to provide a combined negative pressure. In particular, in some embodiments, a negative pressure for fluid uptake from the high pressure vessel may not be required to trigger the additional option of not operating any chamber.

  In some preferred embodiments, the total maximum volume of variable volume chambers employed is not inferior to the volume of the space with which they communicate. For example, in embodiments where there is only a single variable volume chamber, the maximum volume of that chamber will be greater than or equal to the volume of the peristaltic space it communicates with. When two variable volume chambers are used, the sum of their maximum volumes will be greater than or equal to the volume of the peristaltic space. Similar adjustments can be provided for multiple torrent spaces. Furthermore, the description in this specification generally represents the characteristics of chambers that are filled with air, but these chambers may be filled with body fluids, and in one example embodiment, There is also a large chamber volume.

  FIG. 20 is a perspective view of another embodiment of an access device. As shown, the access device includes a needle 22 and a guide wire 44 similar to those described above in other embodiments. In addition, the access device includes a catheter 300 having a structure generally similar to the dilator 24. Further, the catheter 300 may have an elongated body that is partially translucent or transparent as discussed above with respect to the sheath. Further, the catheter may include a hub with a securing structure configured to be removably secured to a corresponding securing structure in the needle. These anchoring structures may be similar to those described above for connecting the needle to the dilator as depicted in FIGS. 2E, 2F, 2G, 3B, and 3D. . According to the fixing structure between the catheter and the needle, unintentional total relative movement between them can be prevented, and if necessary, the needle can be moved relative to the catheter. The needle can be removed to allow it to slide.

  The torsion space can be disposed between the needle 22 and the outer surface of the body of the catheter 300, and the torsion space is such that body fluid within the needle can flow into the space and The body fluid can communicate with the interior of the needle body so that the body fluid can be seen through the translucent or transparent portion of the catheter body.

  In some embodiments, the anchoring structure is a luer-type anchoring connection, a threaded anchoring structure, a removable anchoring structure, or some combination thereof. Preferably, in some embodiments, one fixation structure can be secured with a medical device joint, and another fixation structure can be secured with the needle fixation structure. A plurality of fixing structures can be provided on the hub of the catheter 300.

  Furthermore, the embodiment of FIG. 20 can be combined with other embodiments described in this specification (so that the above-described other embodiments can be combined with each other). It will be clear. For example, the embodiment of FIG. 20 may also include a negative pressure element or a variable volume chamber.

  In yet another embodiment, a surfactant can be provided to further accelerate body fluid uptake by the access device. This surfactant can be applied to any surface in contact with body fluids. Thus, for example, in the embodiment of FIG. 18A, the surfactant can be applied to any one of the needle body, dilator shaft, sheath body, and / or sheath hub.

  In additional embodiments, it may be desirable to allow outflow of air to the ambient atmosphere and prevent outflow of fluid. In such embodiments, a filtering member such as a porous membrane, sufficiently small pores, or other elements can be provided to the access device 20 '. For example, a porous membrane can be provided over the hub opening 205 so that air can enter the flexible hollow body 200 or the pump 215 but prevent passage of bodily fluids such as blood. In other embodiments, such filtering members can be placed inside the tube 215, in the valves 220, 225, or inside a peristaltic space where fluid can be seen.

  The embodiments described in this specification are constructed from conventional biocompatible materials. For example, the needle is preferably composed of ceramic, hard polymer, or metal such as stainless steel, nitinol and the like. Other elements are formed from suitable polymeric materials such as polycarbonate, nylon, polyethylene, high density polyethylene, polypropylene, copolymers such as fluoropolymers, and perfluoro (ethylene-propylene) copolymers, polyurethane polymers or copolymers. can do.

  As mentioned above, the access device according to the present invention can be used to place the catheter elsewhere in the patient's body. Thus, for example, the access device can be used as or with various catheters to drain fluid from an abscess, to drain air from the thoracic cavity, and to access the abdominal cavity. However, it is not limited to these. In such applications, bodily fluids flow into the observation space for displaying when the needle is properly positioned.

  While the invention has been disclosed in the context of several preferred embodiments and examples, those skilled in the art will recognize that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or Or, it will be understood that the invention extends to the use of obvious modifications and equivalents thereof. In addition, although many variations of the invention have been shown and described in detail, other modifications within the scope of the invention will be readily apparent to those skilled in the art based on this disclosure. It will be. It is also anticipated that various combinations or subcombinations of the specific features and aspects of these embodiments can be made and still belong within the scope of the invention. Accordingly, it is understood that various features and aspects of the disclosed embodiments can be combined with each other or substituted for each other to form various aspects of the disclosed invention. Should. Accordingly, the scope of the invention disclosed in this specification should not be limited by the particular disclosed embodiments described above, but should be determined only by correct reading of this disclosure and the claims that follow. Is intended.

Claims (54)

Needles that are made up of holes,
A medical article disposed over at least a portion of the needle and having an outer surface;
A torsion space disposed between the needle and the outer surface of the medical article and in communication with the hole of the needle; and a variable volume chamber in communication with the torsion space to draw fluid from the torsion space An access device for placing a medical article within a body space.   The access device according to claim 1, further comprising a hub to which the medical article is attached.   The access device according to claim 2, wherein the variable volume chamber communicates with the torsional space through a window hole in the hub, the window hole being sealed by the variable volume chamber.   The access device according to claim 1, wherein the medical article is a dilator.   The access device according to claim 1, wherein the medical article is a sheath.   6. The access device of claim 5, further comprising a sheath hub attached to a surface of the sheath, and wherein the variable volume chamber communicates with the perfusion space via a dilator hub.   6. The access device of claim 5, further comprising a dilator.   The dilator hub according to any one of claims 4 and 7, further comprising a dilator hub attached to the surface of the dilator, and wherein the variable volume chamber communicates with the perfusion space via the dilator hub. Access device.   The approach device according to claim 4, wherein the torsion space is installed between the needle and the dilator.   The access device according to claim 7, wherein the torsion space is disposed between the dilator and the sheath.   The access device according to claim 1, wherein the variable volume chamber communicates directly with the torsion space.   12. The access device according to any one of claims 1 to 11, wherein the variable volume chamber comprises a deformable wall.   13. An access device according to any one of the preceding claims, wherein the variable volume chamber comprises a piston-cylinder assembly.   The access device according to claim 1, wherein the needle includes a side window hole, and the torsion space communicates with the hole of the needle through the side window hole.   15. An access device according to any preceding claim, wherein the variable volume chamber is biased towards an expanded position, and the chamber has a larger volume in the expanded position.   16. An access device according to any preceding claim, wherein the variable volume chamber provides sufficient negative pressure to draw fluid from a body cavity selected from the group consisting of veins, arteries and body cavities.   The access device according to any one of claims 1 to 16, further comprising a sealing member that prevents gas from moving between the variable volume chamber and an ambient atmosphere.   The access device according to claim 17, wherein a sheath hub comprises the sealing member, and the sealing member prevents gas movement between the sheath hub and the dilator hub.   The access device according to claim 18, wherein the sealing member is selected from the group consisting of an O-ring, a Bodock seal, and a gasket.   The access device according to claim 1, comprising a plurality of variable volume chambers communicating with the torsion space.   21. An access device according to any preceding claim, wherein the total maximum volume of one or more variable volume chambers employed is not inferior to the volume of the peristaltic space. Needles that are made up of holes,
A medical article disposed over at least a portion of the needle and having an outer surface;
A peristaltic space disposed between the needle and the outer surface of the medical article and communicating with the hole of the needle;
An extended passage that communicates with the torsion space at the first end and further includes a second end;
A negative pressure element that communicates with the second end of the tube, and a filtering member that is provided in at least one of the negative pressure element, the passage, or the peristaltic space and that allows the transfer of air but prevents the transfer of bodily fluids An access device for placing a medical article within a body space.   23. The access device according to claim 22, further comprising a hub to which the medical article is attached, wherein the extending passage communicates with the perfusion space via the hub.   24. An access device according to any of claims 22 and 23, wherein the medical article is a dilator.   24. An access device according to any of claims 22 and 23, wherein the medical article is a sheath.   26. An access device according to any one of claims 22 to 25, wherein the negative pressure element comprises a syringe.   27. An access device according to any one of claims 22 to 26, wherein the negative pressure element comprises a pump.   28. An access device according to any one of claims 22 to 27, wherein the filtering element comprises a porous membrane.   29. An access device according to any one of claims 22 to 28, wherein the extended passage is a tube.   30. An access device according to any one of claims 22 to 29, further comprising a one-way valve disposed between the negative pressure element and the torsional space.   31. An access device according to any one of claims 22 to 30, further comprising a one-way valve disposed between the negative pressure element and the ambient atmosphere.   32. The access device of claim 31, wherein the one-way valve allows direct communication between the negative pressure element and an ambient atmosphere.   33. An access device according to any one of claims 22 to 32, comprising a plurality of negative pressure elements.   34. An access device according to any one of claims 22 to 33, further comprising a fixation structure between the needle and the medical article. Inserting an access device into a body cavity, the access device comprising a needle, a medical article, a torsion space disposed between the needle and an outer surface of the medical article, and a variable communicating with the torsion space Comprising a volume chamber, wherein the variable volume chamber is in a deflated low volume position;
Expanding the volume of the variable volume chamber to create a negative pressure in the variable volume chamber that is sufficient to draw body fluid from the body cavity into the torsion space; and A method of approaching a body cavity comprising observing from outside the access device.   36. The method of claim 35, wherein the step of expanding the volume of the variable volume chamber comprises releasing the variable volume chamber.   38. The method of claim 36, wherein the step of expanding the volume further comprises automatically expanding the variable volume chamber upon release of the variable volume chamber. 36. The method further includes securing the needle to the medical article and unlocking the needle from the medical article to prevent relative movement between the needle and the medical article. 38. The method according to any one of 37 to 37. An elongated needle body with a distal end, a hub extending from the needle body, and a fixed structure disposed on a surface of the hub; and a needle body disposed on the surface of the needle body A catheter that is movable relative to
The catheter comprises a flexible catheter body and a fixation structure configured to interengage with the needle fixation structure to prevent relative movement between the needle and the catheter. The catheter fixing structure is further configured to interengage with a medical joint;
No dilator between the needle and the catheter;
An access device for placing a catheter within a body space.   40. The access device of claim 39, wherein the fixation structure prevents relative movement between the catheter and the needle when the catheter and the needle are adjacent.   40. The catheter is configured such that when inserted into a body cavity, the catheter can be safely bent at a non-twisted extreme angle to maintain an open flow path therethrough. 41. An access device according to any of 40 and 40.   42. An access device according to any one of claims 39 to 41, wherein the catheter does not have sufficient structural strength to expand the hole created by the needle.   43. An access device according to any one of claims 39 to 42, wherein the catheter is not self-supporting and tilts substantially downward under gravity when not supported by the needle. . An elongate needle body with a distal end, a hub extending from the needle body, and a needle comprising a fixation structure disposed on a surface of the hub;
A catheter comprising an elongated catheter body disposed at least partially on the surface of the needle body and at least partially translucent or transparent, and a hub extending from the catheter body, the hub Is configured to be removably secured to the needle securing structure and to prevent unintentional total relative movement between the needle and the catheter, and the needle securing structure. A catheter comprising a fixation structure configured to be removable from the needle and slidable relative to the catheter;
A peristaltic space disposed between the needle and the outer surface of the catheter body so that bodily fluid inside the needle body flows into the space and is translucent or transparent to the catheter body A torsional space communicating with the inside of the needle body so that it can be seen through the portion of the needle body, and is pre-mounted in the needle and has a length longer than the length of the needle body, and the needle body An access device for placing a catheter inside a body space, comprising a guide wire that can be slid through the body.   45. The access device of claim 44, wherein the catheter hub fixation structure is configured to engage a luer-type fixation connector joint on a surface of a medical article.   46. An access device according to any of claims 44 and 45, wherein the catheter hub fixation structure includes threads.   47. An access device according to any one of claims 44 to 46, wherein the catheter hub securing structure is further configured to be removably secured to a medical fitting.   The catheter hub fixation structure comprises a first fixation structure element and a second fixation structure element, wherein the first fixation structure element is configured to be removably fixed to a medical device joint; 48. An access device according to any one of claims 44 to 47, wherein the second anchoring structure element is configured to be removably anchored to the needle anchoring structure.   49. The catheter hub fixation structure and the needle hub fixation structure of claim 44, wherein the catheter hub fixation structure is interconnected when the catheter hub is positioned adjacent to the needle hub. The access device described.   50. An access device according to any one of claims 44 to 49, wherein the catheter is configured to bend at an acute angle without twisting.   51. An access device according to any one of claims 44 to 50, wherein the catheter does not have sufficient axial structural strength to expand the hole created by the needle.   52. An access device according to any one of claims 44 to 51, wherein the catheter is not self-supporting and tilts substantially downward under gravity when not supported by the needle. .   53. An access device according to any one of claims 44 to 52, further comprising a negative pressure element in communication with the torsion space.   The guidewire includes a proximal end and a distal end, the distal end being disposed inside the needle body and the proximal end disposed outside the needle. 54. Access according to any one of claims 44 to 53, wherein the distal portion of the needle can be bent away from the axis of the needle and can be removed from the needle hub and discarded. apparatus.